The Effect of Antimicrobial Photodynamic Therapy on the Success of Root Canal Treatment

NCT06634745 | Completed

• 1 other identifier: 2023/058
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The decontamination of the root canal system from pathological microflora is essential for the success of endodontic treatment. Mechanical instrumentation and irrigation solutions, known as the chemomechanical process, are typically used for this purpose. However, due to the complex anatomy of teeth, residual microorganisms can remain, potentially affecting treatment success and weakening dentin walls. This has led to the development of more effective irrigation and disinfection systems. Antimicrobial photodynamic therapy (aPDT) has emerged as a promising adjunct to traditional methods. aPDT is used to eliminate resistant microorganisms in various medical fields, including dentistry, and has been shown to effectively destroy oral bacteria in both planktonic and biofilm forms. However, aPDT is not a replacement for traditional endodontic procedures but can be used as an adjunct in root canal disinfection. aPDT works through the presence of a photosensitizer, a radiation source with a sufficient wavelength, and oxygen, producing reactive oxygen species (ROS) that have a bactericidal effect. Methylene blue (MB) is a common photosensitizer, but it can cause tooth discoloration and is difficult to remove. Alternatives to MB are being sought. Different activation techniques, such as passive ultrasonic irrigation (PUI) and sonic activation systems (SAS), have been developed to enhance the effectiveness of irrigation solutions. Studies have shown that PUI and SAS have similar effectiveness in traditional endodontic irrigation. Enterococcus faecalis is a particularly resistant bacterium involved in endodontic infections. While MB's effectiveness against E. faecalis is documented, there is a lack of studies comparing its effectiveness with ultrasonic and sonic systems in necrotic and periapical lesion teeth. There is also limited research on the discoloration potential and postoperative pain of MB when used with various activation systems. The study hypothesizes that there will be no significant difference in lesion healing, postoperative pain, and discoloration potential with different activation systems using aPDT.

Conditions

Antimicrobial Photodynamic Therapy

Keywords

Antimicrobial photodynamic therapy; Methylene blue; Apical periodontitis

Outcome Measures

Primary Outcomes (1)

• Reduction in Bacterial Load

  This study aims to evaluate the effectiveness of antimicrobial photodynamic therapy (aPDT) using different irrigation activation techniques in teeth with apical periodontitis. The study will be conducted as a randomized, parallel-group clinical trial with four intervention groups: Standard Needle Irrigation (SNI), Passive Ultrasonic Irrigation (PUI), EndoActivator (EA), and EDDY.

  Up to 6 months

Study Arms (4)

Standard Needle Irrigation (SNI) with MB Activation

EXPERIMENTAL

In this group, the activation of MB (Merck KgaA) was performed using a 30G NaviTip (Cermaked) with 1 activation cycle. The 30G NaviTip (Cermaked) was placed in the root canal 1 mm short of the working length and used with a 3-4 mm amplitude. The MB (Merck KgaA) solution was activated for 1 minute and renewed during the treatment

Procedure: Standard Needle Irrigation (SNI)

Passive Ultrasonic Irrigation (PUI) with MB Activation

EXPERIMENTAL

In this group, the activation of MB (Merck KgaA) was performed using Ultra X (Eighteeth, Changzhou, China) and a #25 ultrasonic endodontic tip (Eighteeth) at a frequency of 45 kHz. The ultrasonic endodontic tip was placed in the root canal 1 mm short of the working length and the MB (Merck KgaA) solution was activated for 1 minute. During the activation process, care was taken to ensure the ultrasonic endodontic tip moved freely within the canal, and the MB solution was renewed during the treatment.

Procedure: Passive Ultrasonic Irrigation (PUI

EndoActivator(EA) with MB Activation

EXPERIMENTAL

In this group, the activation of MB (Merck KgaA) was performed using a polymer EA tip (Dentsply, Tulsa, OK) with a 25.04 tip diameter, which was placed into the canal 2 mm short of the working length. The activation procedure was carried out for 1 minute using the EA sonic irrigation device at 10,000 cycles, and the MB (Merck KgaA) solution was renewed during the treatment.

Procedure: EndoActivator (EA)

EDDY with MB Activation

EXPERIMENTAL

In this group, the activation of MB (Merck KgaA) was performed using a polymer EDDY tip (VDW, Munich, Germany) with a 25.04 tip diameter and the Sonicmax sonic device (Maximum Dental Inc., Secaucus, NJ, USA) with one activation cycle. The EDDY (VDW) tip was placed in the canal 1 mm short of the working length and moved in a corono-apical direction at a frequency of 6 kHz and an amplitude of 5 mm for 1 minute to achieve MB activation. The MB (Merck KgaA) solution was renewed during the treatment.

Procedure: EDDY

Interventions

Standard Needle Irrigation (SNI) PROCEDURE

Standard Needle Irrigation (SNI): Utilizes standard needle irrigation techniques for activating the antimicrobial solution within the root canal.

Standard Needle Irrigation (SNI) with MB Activation

Passive Ultrasonic Irrigation (PUI PROCEDURE

Passive Ultrasonic Irrigation (PUI): Employs ultrasonic energy to enhance the activation and effectiveness of the antimicrobial solution in the root canal.

Passive Ultrasonic Irrigation (PUI) with MB Activation

EndoActivator (EA) PROCEDURE

EndoActivator (EA): Uses a sonic activation device to facilitate the distribution and activation of the antimicrobial solution in the root canal.

EndoActivator(EA) with MB Activation

EDDY PROCEDURE

EDDY: Involves the use of a sonic activation device that operates at high frequency to activate the antimicrobial solution within the root canal. These descriptions focus on the general method and purpose of each intervention without delving into the specific procedural details already covered in the arm/group descriptions.

EDDY with MB Activation

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Teeth that had not undergone previous root canal treatment.
• Teeth with a single root and a single canal.
• Teeth with apical periodontitis.
• Teeth with periodontal lesion size less than 5 mm.
• Teeth without sinus tract or acute apical abscess.
• Patients without systemic diseases.
• Patients not pregnant.
• Patients who volunteered to participate in the study.
• Patients who agreed to attend follow-up sessions.

You may not qualify if:

• Patients using medications such as antihypertensives or antidiabetics that could affect root canal treatment outcomes.
• Patients using corticosteroids or antibiotics.
• Patients with acute pain or extraoral swelling.
• Patients with a history of sinus tract or acute apical abscess.
• Patients with systemic diseases.
• Patients who are pregnant.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences Gulhane

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• Asnaashari M, Mojahedi SM, Asadi Z, Azari-Marhabi S, Maleki A. A comparison of the antibacterial activity of the two methods of photodynamic therapy (using diode laser 810 nm and LED lamp 630 nm) against Enterococcus faecalis in extracted human anterior teeth. Photodiagnosis Photodyn Ther. 2016 Mar;13:233-237. doi: 10.1016/j.pdpdt.2015.07.171. Epub 2015 Aug 1.

  PMID: 26241781 RESULT

• Er Karaoglu G, Ugur Ydin Z, Erdonmez D, Gol C, Durmus M. Efficacy of antimicrobial photodynamic therapy administered using methylene blue, toluidine blue and tetra 2-mercaptopyridine substituted zinc phthalocyanine in root canals contaminated with Enterococcusaecalis. Photodiagnosis Photodyn Ther. 2020 Dec;32:102038. doi: 10.1016/j.pdpdt.2020.102038. Epub 2020 Oct 1.

  PMID: 33010484 RESULT

• da Silva CC, Chaves Junior SP, Pereira GLD, Fontes KBFDC, Antunes LAA, Povoa HCC, Antunes LS, Iorio NLPP. Antimicrobial Photodynamic Therapy Associated with Conventional Endodontic Treatment: A Clinical and Molecular Microbiological Study. Photochem Photobiol. 2018 Mar;94(2):351-356. doi: 10.1111/php.12869. Epub 2018 Jan 19.

  PMID: 29166538 RESULT

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Officials

• Özge Hür Şahin, DDS

  University of Health Sciences Gülhane

  STUDY DIRECTOR

• Zeliha Uğur Aydın, Assoc. Prof.

  University of Health Sciences Gülhane

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants: The participants in this study were blinded to their treatment allocation. They did not know whether they were receiving antimicrobial photodynamic therapy (aPDT) with standard needle irrigation, EDDY sonic activation system, passive ultrasonic irrigation, or Endoactivator sonic activation system.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a randomized, parallel-group clinical trial evaluating the effectiveness of antimicrobial photodynamic therapy (aPDT) using different irrigation activation techniques in teeth with apical periodontitis. Sixty patients with single-rooted, single-canal teeth were included. Participants were randomly assigned to four groups: aPDT with standard needle irrigation (SII), aPDT with Endoactivator, aPDT with passive ultrasonic irrigation (PUI), and aPDT with EDDY. All groups received aPDT using methylene blue, following standard endodontic procedures. The primary outcome was the efficacy of microbial reduction in the root canal system. Secondary outcomes included lesion healing, postoperative pain, and discoloration potential. Data were analyzed to compare the effectiveness of different techniques. The null hypothesis was that there would be no significant difference among the groups in terms of lesion healing, postoperative pain, and discoloration potential.

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 10, 2024
• Study Start: June 20, 2023
• Primary Completion: March 15, 2024
• Study Completion: July 14, 2024
• Last Updated: October 10, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From baseline to 6 months post-treatment
• Access Criteria: undecided

Locations

TU (1)